Elon Musks Neuralink Receives FDA Approval to Study Brain Implants

Elon Musk’s Neuralink Receives FDA Approval to Study Brain Implants in Humans

May 25 (Portal) – Elon Musk’s brain implant company Neuralink announced on Thursday that it had received US Food and Drug Administration (FDA) approval to start its first human clinical trial.

Musk has predicted at least four times since 2019 that his medical device company would soon begin human trials of a brain implant to treat intractable conditions like paralysis and blindness.

But the company, founded in 2016, didn’t apply for FDA approval until early 2022 — and the agency denied the request, seven current and former employees told Portal in March.

The FDA approval comes as U.S. lawmakers earlier this month asked regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.

Neuralink has already been the subject of federal investigations.

Portal reported on December 5 that the USDA’s inspector general, on behalf of a federal prosecutor, is investigating possible violations of the Animal Welfare Act, which regulates how researchers treat and test certain species of animals.

The investigation also looked at the USDA’s oversight of Neuralink.

In a tweet Thursday, Neuralink said the company is not yet open for a clinical trial.

“This is the result of the incredible work of the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet on Thursday.

Neuralink is developing a brain implant to help paralyzed people walk again and cure other neurological disorders.

The FDA did not immediately respond to a Portal request for comment.

Reporting by Akriti Sharma in Bengaluru; Edited by Anil D’Silva

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